Conditions such as rectocele, cystocele, enterocele, vaginal prolapse, and protocele involve tissues or organs that have been damaged, prolapsed, weakened, or otherwise herniated. A prolapse refers to the slipping of an organ, or organ part, from its normal position. For example, a prolapse of the rectum refers to the protrusion of the rectum through the anus. Rectocele is the prolapse of the rectum into the perineum. A prolapse of the uterus refers to the falling of the uterus into the vagina due to stretching and laxity of its supporting structures. Vaginal vault prolapse refers to the prolapse of the cephalad extreme of the vaginal wall toward, through, and beyond the introitus. Cystocele (i.e., vesicocele) is a hernia formed by the downward and backward displacement of the urinary bladder toward the vaginal orifice, due most commonly to weakening of the musculature during childbirth. However, any abnormal descent of the anterior vaginal wall and bladder base at rest or with strain is considered cystocele. Enterocele is a hernia of the intestine, though the term is also used to refer specifically to herniation of the pelvic peritoneum through the rectouterine pouch (i.e., posterior vaginal, rectovaginal, cul-de-sac, or Douglas' pouch hernia). Proctocele is a prolapse of the mucous coat of the rectum due mostly from relaxation of the sphincter. Treatment of these conditions frequently requires a sling, such as a mesh sling, implanted at the anatomical site-requiring repair.
Stress urinary incontinence (SUI) primarily affects women and generally is caused by two conditions that may occur independently or in combination, namely, intrinsic sphincter deficiency (ISD) and hypermobility. In ISD, the urinary sphincter valve, located within the urethra, fails to close properly, causing urine to leak out of the urethra during stressful actions. Hypermobility is a condition in which the pelvic floor is distended, weakened, or damaged, causing the bladder neck and proximal urethra to rotate and descend in response to increases in intra-abdominal pressure (e.g., due to sneezing, coughing, straining, etc.), resulting in insufficient response time to promote urethral closure and, consequently, in urine leakage and/or flow.
Biological factors that may affect hypermobility include: poor endopelvic fascia muscle tone (from, for example, age or limited activity), endopelvic fascia muscle stretch/tear from trauma (e.g., childbirth), endopelvic fascia/arcus tendenious (muscle/ligament) separation (lateral defect), hormone (e.g., estrogen) deficiency, concombinant defects (e.g., cystocele, enterocele, and ureteral prolapse), and vaginal prolapse. Traditional treatment methods include urethra or bladder neck stabilization slings in which a sling is placed under the mid-urethra or bladder neck to provide a platform preventing over distention.
Slings are traditionally placed under the urethra or bladder neck to provide a urethral platform limiting endopelvic fascia drop while providing compression to the urethral sphincter to improve coaptation. The urethral placement location provides mechanical stability to a less moveable anatomical structure. Bladder neck slings traditionally have been affixed in the desired location using a bone anchoring method. Mid-urethral slings, being placed in a low mobility area, may be placed using an anchorless approach. Recognizing that minimal tension, if any, is necessary, a physician may need only to secure a mid-urethra sling through the endopelvic fascia. The sling in this placement provides a fulcrum about which the pelvic floor will drop (taking advantage of the hypermobility condition of the patient) and a urethral “kink” or higher resistance to obstruct urine flow during high stress conditions.
A known method for stabilizing organs and tissues within the pelvic region involves the use of bone anchors. Deployment of a bone anchor requires drilling a hole in a bone, either by using a separate drilling instrument or by utilizing the anchor itself as a drilling tool. Bone anchors generally have one or more barbs that project outward to prevent the anchor from exiting the hole. Such anchors generally are not amenable to implantation in soft tissues, since the barbs would tear the soft tissue, causing irritation and/or passage of the anchor back through the tissue.
Other known methods include making one or more incisions in a patient's abdomen. For example, one method for treating female stress urinary incontinence involves supporting the urethra with an implant anchored in the patient's skin after the implant has been passed through the skin of the patient's abdomen.